Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products
The application of Quality by Design (QbD) requires that the distribution process be widely known across the development and operational components in the company. Currently, few companies have this process in mind during the development of the product. The adoption of a risk-based approach compares and contrasts the capability of the distribution process with the demonstrated requirements of the product. Regulators and industry-leading companies are now recognizing the creation of product design space, and the evaluation of physical stability early in the product life cycle. Leading academic institutions are demonstrating the relationship between physical stability of the product and the unavoidable physical hazards inherent in the distribution system. Application of QbD principles focused on defining the product design space for physical stability will accelerate product development and provide valuable insights to effective commercialization activities.
KeywordsTech transfer Distribution Physical stability Design space Supply chain Quality agreement Risk based
- Moore WV, Leppert P (1980) Role of aggregated human growth-hormone (Hgh) in development of antibodies to Hgh. J Clin Endocrinol Metab 51(4):691–697Google Scholar
- Murphy MM, Swarts S, Mueller BM, Geer P van der, Manning MC, Fitchmun MI (2013) Protein instability following transport or storage on dry ice. Nat Methods 10:278–279Google Scholar
- Ratner RE, Phillips TM, Steiner M (1990) Persistent cutaneous insulin allergy resulting from high molecular weight insulin aggregates. Diabetes 39:728Google Scholar
- Schellekens H (2002) Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther 24(11):1720–1740Google Scholar